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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891511
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Oon Corp. Resources
# 59, Senawang Indust Estate
70450 Seremban, Negeri
Sembilan, Malaysia,  MY
Applicant Contact KOH OON
Correspondent
Oon Corp. Resources
# 59, Senawang Indust Estate
70450 Seremban, Negeri
Sembilan, Malaysia,  MY
Correspondent Contact KOH OON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
Decision Date 03/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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